FDA.reportPublic FDA data

Methylprednisolone

Product NDC
59746-003
11-digit product format
597460003
Labeler code
59746
Product ID
59746-003_f7ee0424-d881-4ae1-98be-e8863a8f78fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylprednisolone
Dosage form
TABLET
Route
ORAL
Labeler
JUBILANT CADISTA PHARMACEUTICALS INC.
Application
ANDA040189
Marketing category
ANDA
Marketing start
1997-10-31
Marketing end
0000-00-00
Substance
METHYLPREDNISOLONE
Active strength
16 mg/1
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59746-003-142025-07-29C16284748780-13b156c62-249f-fb37-e063-e6dba90a4e07METHYLPREDNISOLONE TABLETS, USP Rx Only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59746-003-14EA - Each59746-00324808f6f-4a9c-478c-a3fa-a8c51b16cc0712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MethylprednisoloneACTIVE INGREDIENTX4W7ZR7023METHYLPREDNISOLONE (METHYLPREDNISOLONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]2
MethylprednisoloneACTIVE MOIETYX4W7ZR7023METHYLPREDNISOLONE (METHYLPREDNISOLONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]2
Anhydrous LactoseINACTIVE INGREDIENT3SY5LH9PMKMETHYLPREDNISOLONE (METHYLPREDNISOLONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]2
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UMETHYLPREDNISOLONE (METHYLPREDNISOLONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]2
Lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XMETHYLPREDNISOLONE (METHYLPREDNISOLONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]2
Magnesium stearateINACTIVE INGREDIENT70097M6I30METHYLPREDNISOLONE (METHYLPREDNISOLONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]2
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4METHYLPREDNISOLONE (METHYLPREDNISOLONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]2
Sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JMETHYLPREDNISOLONE (METHYLPREDNISOLONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]2
Sodium Starch Glycolate Type A PotatoINACTIVE INGREDIENT5856J3G2A2METHYLPREDNISOLONE (METHYLPREDNISOLONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]2
Starch, CornINACTIVE INGREDIENTO8232NY3SJMETHYLPREDNISOLONE (METHYLPREDNISOLONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-003METHYLPREDNISOLONE (METHYLPREDNISOLONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]7Legacy NDC20240526_7bf4d3d3-3f8a-4e20-9194-061658efca61.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59746-003-145974600031450 TABLET in 1 BOTTLE (59746-003-14) 50 tablet1997-10-310000-00-00NoNoCurrent